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Review of the Uniform Recall Procedure for Therapeutic Goods
The Uniform Recall Procedure for Therapeutic Goods (URPTG) outlines the procedure to be used in the event of a recall and defines the actions and responsibilities of health authorities and sponsors when therapeutic goods for use in humans, for reasons relating to their quality, safety or efficacy, are to be removed from supply or use, or subject to corrective action.
The URPTG is the result of an agreement between the therapeutic goods industry, the Therapeutic Goods Administration (TGA) and State/Territory health authorities. It is oversighted by the National Coordinating Committee on Therapeutic Goods (NCCTG).
In 2002, following consultation with the NCCTG, the TGA engaged an independent consultant to review the URPTG. The consultancy was to review the recall processes for therapeutic goods undertaken in accordance with the URPTG to ensure that:
- The URPTG is effective in defining the action to be taken by health authorities and sponsors when therapeutic goods for use in humans, for reasons relating to their quality, safety and efficacy, or for any other reason are removed form supply or use, or subject to corrective action.
- The actions and processes defined or utilised under the URPTG and the Therapeutic Goods Act 1989 are effective and appropriate for Australia in the context of:
- being comprehensive, streamlined, timely and effective from the public health and safety and cost perspective;
- facilitating the cooperation of all parties who are involved in recalls e.g. sponsors, retailers and health care professionals; and
- being compatible with the proposed trans-Tasman harmonisation of the regulation of therapeutic goods.
The completion of the review in 2003 was deferred to allow the consultant to investigate issues arising from the recall of goods manufactured by Pan Pharmaceuticals Ltd.
A draft report was released for stakeholder consultation in November 2003. Comments were reviewed and incorporated in the final report which was accepted by the NCCTG at its April 2004 meeting.
- Executive summary
- List of recommendations
- Appendix 1 Persons consulted in the course of the Review of the Uniform recall procedure for Therapeutic Goods
- Appendix 2 EU criteria for Batch Recalls for Quality Defects
- Appendix 3 A risk assessment methodology when considering recalls
- Appendix 4 Key Principles in Environmental Health Risk Assessment
- Appendix 5 Key sections of the Therapeutic Goods Act that particularly relate to recalls (not including penalties etc)